Rudy M M A Nuijts1, Soraya M R Jonker2, Robert A Kaufer1, Ruth Lapid-Gortzak1, Javier Mendicute1, Cristina Peris Martinez1, Stefanie Schmickler1, Thomas Kohnen1. 1. From the University Eye Clinic (Nuijts, Jonker), Maastricht University Medical Center, Maastricht, and the Ophthalmology Department (Lapid-Gortzak), Academic Medical Center, Amsterdam, the Netherlands; Kaufer Clinica de Ojos (Kaufer), Buenos Aires, Argentina; Servicio de Oftalmologia (Mendicute), Hospital Universitario Donostia, San Sebastian, and the Fundacion Oftalmologica del Mediterraneo (Martinez), Valencia, Spain; Augen-Zentrum-Nordwest (Schmickler), Ahaus, and the Department of Ophthalmology (Kohnen), Goethe-University, Frankfurt, Germany. 2. From the University Eye Clinic (Nuijts, Jonker), Maastricht University Medical Center, Maastricht, and the Ophthalmology Department (Lapid-Gortzak), Academic Medical Center, Amsterdam, the Netherlands; Kaufer Clinica de Ojos (Kaufer), Buenos Aires, Argentina; Servicio de Oftalmologia (Mendicute), Hospital Universitario Donostia, San Sebastian, and the Fundacion Oftalmologica del Mediterraneo (Martinez), Valencia, Spain; Augen-Zentrum-Nordwest (Schmickler), Ahaus, and the Department of Ophthalmology (Kohnen), Goethe-University, Frankfurt, Germany. Electronic address: soraya.jonker@mumc.nl.
Abstract
PURPOSE: To assess the clinical visual outcomes of bilateral implantation of Restor +2.5 diopter (D) multifocal intraocular lenses (IOLs) and contralateral implantation of a Restor +2.5 D multifocal IOL in the dominant eye and Restor +3.0 D multifocal IOL in the fellow eye. SETTING: Multicenter study at 8 investigative sites. DESIGN: Prospective randomized parallel-group patient-masked 2-arm study. METHODS: This study comprised adults requiring bilateral cataract extraction followed by multifocal IOL implantation. The primary endpoint was corrected intermediate visual acuity (CIVA) at 60 cm, and the secondary endpoint was corrected near visual acuity (CNVA) at 40 cm. Both endpoints were measured 3 months after implantation with a noninferiority margin of Δ = 0.1 logMAR. RESULTS: In total, 103 patients completed the study (53 bilateral, 50 contralateral). At 3 months, the mean CIVA at 60 cm was 0.13 logMAR and 0.10 logMAR in the bilateral group and contralateral group, respectively (difference 0.04 logMAR), achieving noninferiority. Noninferiority was not attained for CNVA at 40 cm; mean values at 3 months for bilateral and contralateral implantation were 0.26 logMAR and 0.11 logMAR, respectively (difference 0.15 logMAR). Binocular defocus curves suggested similar performance in distance vision between the 2 groups. Treatment-emergent ocular adverse events rates were similar between the groups. CONCLUSION: Bilateral implantation of the +2.5 D multifocal IOL resulted in similar distance as contralateral implantation of the +2.5 D multifocal IOL and +3.0 D multifocal IOL for intermediate vision (60 cm), while noninferiority was not achieved for near distances (40 cm).
RCT Entities:
PURPOSE: To assess the clinical visual outcomes of bilateral implantation of Restor +2.5 diopter (D) multifocal intraocular lenses (IOLs) and contralateral implantation of a Restor +2.5 D multifocal IOL in the dominant eye and Restor +3.0 D multifocal IOL in the fellow eye. SETTING: Multicenter study at 8 investigative sites. DESIGN: Prospective randomized parallel-group patient-masked 2-arm study. METHODS: This study comprised adults requiring bilateral cataract extraction followed by multifocal IOL implantation. The primary endpoint was corrected intermediate visual acuity (CIVA) at 60 cm, and the secondary endpoint was corrected near visual acuity (CNVA) at 40 cm. Both endpoints were measured 3 months after implantation with a noninferiority margin of Δ = 0.1 logMAR. RESULTS: In total, 103 patients completed the study (53 bilateral, 50 contralateral). At 3 months, the mean CIVA at 60 cm was 0.13 logMAR and 0.10 logMAR in the bilateral group and contralateral group, respectively (difference 0.04 logMAR), achieving noninferiority. Noninferiority was not attained for CNVA at 40 cm; mean values at 3 months for bilateral and contralateral implantation were 0.26 logMAR and 0.11 logMAR, respectively (difference 0.15 logMAR). Binocular defocus curves suggested similar performance in distance vision between the 2 groups. Treatment-emergent ocular adverse events rates were similar between the groups. CONCLUSION: Bilateral implantation of the +2.5 D multifocal IOL resulted in similar distance as contralateral implantation of the +2.5 D multifocal IOL and +3.0 D multifocal IOL for intermediate vision (60 cm), while noninferiority was not achieved for near distances (40 cm).
Authors: César Vilar; Wilson Takashi Hida; André Lins de Medeiros; Klayny Rafaella Pereira Magalhães; Patrick Frensel de Moraes Tzelikis; Mario Augusto Pereira Dias Chaves; Antônio Francisco Pimenta Motta; Pedro Carlos Carricondo; Milton Ruiz Alves; Walton Nosé Journal: Clin Ophthalmol Date: 2017-08-01